generational value differences impacting the perceptions
TRANSCRIPT
Generational Value Differences Impacting the Perceptions of and Willingness for
Clinical Trial Participation
by
April M. Nelson
Research Project
Submitted to the School of Health Sciences
Eastern Michigan University
in partial fulfillment of the requirements
for the degree of
MASTER OF SCIENCE
in
Clinical Research Administration
Advisor: Irwin Martin, Ph.D.
November 7, 2014
Ypsilanti, Michigan
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Acknowledgements
I would like to thank Dr. Kenneth Getz and the Center for Information and Study on
Clinical Research Participation (CISCRP) for their generosity in granting me permission
to utilize the results of their research efforts.
Notably, I would like to Dr. Irwin Martin for his genuine spirit, kind heart, and patient
support of me throughout my academic and research endeavors – and for that, I am
forever grateful.
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Abstract
Subject recruitment for clinical trial participation presents as a significant problem and is
the primary reason for drug development delays. Data from the Center for Information
and Study on Clinical Research Participation (CISCRP) Perceptions and Insight study,
indicate that the 18 – 34 year old, Generation Y, subgroup were the least willing to
participate in a clinical trial. Statistically significant differences exist between Generation
Y compared to older age groups. Generational perceptions and value differences were
explored via corporate and sociological research findings to determine why disparities
exist among age groups regarding the willingness for clinical trial participation.
Preliminary results, however, indicate that the findings are truly generational and not
simply age-related.
Keywords: Generation Y, clinical trial participation, medical research study
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Table of Contents
CHAPTER 1: INTRODUCTION AND BACKGROUND ....................................................................... 1
STATEMENT OF THE PROBLEM .............................................................................................................................. 4
PURPOSE AND SIGNIFICANCE ................................................................................................................................. 4
HYPOTHESIS .............................................................................................................................................................. 5
LIMITATIONS ............................................................................................................................................................. 5
CHAPTER 2: LITERATURE REVIEW ................................................................................................... 6
CHAPTER 3: RESEARCH BACKGROUND AND METHODOLOGY ................................................ 9
METHOD ................................................................................................................................................................. 10
Null Hypothesis ...................................................................................................................................................... 10
Participants ............................................................................................................................................................. 10
Materials and Procedure .................................................................................................................................. 10
CHAPTER 4: RESULTS .......................................................................................................................... 13
CHAPTER 5: DISCUSSION ................................................................................................................... 15
TEMPORAL FACTORS ............................................................................................................................................ 18
SOCIAL MEDIA ....................................................................................................................................................... 19
DIGITAL REVOLUTION AND INFORMATION SEEKING ...................................................................................... 20
GENERATIONAL VALUE FACTORS ....................................................................................................................... 21
CHAPTER 6: CONCLUSION .................................................................................................................. 23
REFERENCES ........................................................................................................................................... 24
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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List of Tables
Table 1. Historical Events Experienced by Generation Y during Developmental Years .. 8
Table 2. Number of North American Respondents by Age Group (CISCRP, 2013) ...... 12
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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List of Figures
Figure 1. Willingness to Participate in a Clinical Research Study – Not At All Willing .. 3
Figure 2. Willingness to Participate in a Clinical Research Study – How Willing ......... 14
Figure 3. Willingness to Participate in a Clinical Research Study – 1994 Trauth ........... 17
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Chapter 1: Introduction and Background
In the quest for new drug development, human subject recruitment for clinical
trial participation is a significant problem in the biomedical industry, causing untimely
delays, financial setbacks, and the frequent need for global outsourcing (Trauth, Musa,
Siminoff, Jewell, & Ricci, 2000). The pharmaceutical industry spends an average of $45
billion dollars on research and development, with at least 40% of this sum dedicated to
conducting clinical trials (Petryna, 2009). The primary reason for clinical trial delays is
due to challenges in patient recruitment (Findlay, 2009). Consequentially, as of 2005, an
average of 40% of pharmaceutical and biotech clinical trials were conducted in
developing countries (Petryna, 2009).
Yet, according to CenterWatch, 94% of people recognize the importance of
participating in clinical research, and as many as 87% of the general population are
willing to participate in a clinical research study (The Center for Information and Study
on Clinical Research Participation [CISCRP], 2013). Additionally, a 2004 Research
America Health Poll, reports 68% of respondents believe clinical research is of great
value, and 55% of respondents indicated they would likely participate in a medical
research study (Woolley & Propst, 2005). However, the 2013 CISCRP survey revealed
that persons between the ages of 18 to 34 were the least willing to participate in a clinical
research study (see Figure 1). This subgroup represents the Generation Y population. By
viewing this problem in relation to society’s hope to advance global healthcare initiatives
- the future of recruiting potential clinical trial participants is unknown.
The current literature offers many reasons why people participate in clinical trials.
For example, according to a CenterWatch survey, respondents cited finding a relief or
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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cure (60%), helping advance science (23%), earning extra money (11%), and receiving
better medical care (6%) as the top reasons for participating in a clinical trial (Getz &
Borfitz, 2003). Motivations for clinical trial participation are also reinforced globally, to
include wanting therapeutic options, financial compensation, access to ancillary care,
curiosity or scientific interest, and demonstrating altruism (Nappo, Iafrate, Sanchez,
2013; Stunkel & Grady, 2011).
Additionally, many studies have been conducted outlining reasons why eligible
participants would not want to participate in a clinical trial – examples include not
wanting a placebo, concern over side effects and potential risks, worries about loss of
treatment upon trial completion, utilization of current standard treatments, inconvenience,
and unanticipated costs (Getz & Borfitz, 2003; Brintnall-Karabelas, Sung, Cadman,
Squires, Whorton, & Pao, 2011). There are even studies that explore the decision-making
processes potential subjects apply when determining whether or not to participate in a
clinical trial (Guadagnolai & Ward, 1998; Verheggen, Nieman, & Jonkers, 1998).
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Figure 1. Willingness to Participate in a Clinical Research Study – Not At All Willing
Figure 1. Graphical representation of survey respondent data stating respondents are “not at all
willing” to participate in a clinical research study. Adapted from The Center for Information & Study
on Clinical Research Participation (CISCRP), 2013, 2013 Perceptions and insights study: Public and
patient perceptions of clinical research. Retrieved on November 15, 2013, from
http://www.ciscrp.org/ professional/reports/
5%
3%
1%
2%
1%
0%0%
1%
2%
3%
4%
5%
6%
18-34 35-44 45-54 55-64 65-74 75+
Age Ranges
2013 CISCRP International Age-Based Data "Not At All Willing"
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Statement of the Problem
Understanding these data is of utmost importance, yet, there has been no
identifiable research evaluating the reasons why differences exist among age groups
regarding the perceptions of and willingness for clinical trial participation. The
biomedical research industry would benefit from engaging in a directive to increase
participation in clinical trials. Healthcare and research communities are placing greater
emphasis on individual preferences by initiating patient-centered practices, establishing
meaningful patient-physician relationships, and personalizing information - for instance,
during the informed consent process (Siegal, Bonnie, Appelbaum, 2012; Epstein &
Peters, 2009; Brintnall et al., 2011). However, recognizing factors, such as generational
values, that influence prospective subjects’ decision-making processes may potentially
provide the framework necessary for prosperous subject recruitment and clinical trial
participation (Brintnall et al., 2011).
Purpose and Significance
According to White (2013), generational thinking is important to understand by
directing attention to the intent and various elements that influence the context of
perceptions and basis for choices. As perceptions shape willingness, this includes
viewing generationalism in the milieu of clinical trial participation.
The primary objective of this study was to analyze the 2013 CISCRP survey for
age-based data to determine if statistically significant differences exist among the 18 – 34
year old, Generation Y subgroup, compared to older age groups regarding willingness to
participate in a clinical trial. Secondary objectives include exploring Generation Y value
differences that may impact the perception of clinical trial participation. As such, this
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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information may contribute to the body of knowledge the biomedical research
community has concerning human subject recruitment within this age group as future
participants of clinical trials.
Hypothesis
It is hypothesized, based upon the media-hyped life-experiences, individualistic
attitudinal differences, and defining generational characteristics, that Generation Y will
represent statistically significant differences in their willingness to participate in a clinical
trial compared to older age groups or generations.
Limitations
It is unreasonable to suggest the only factor impacting the perceptions of and
willingness for clinical trial participation is generational value differences among distinct
age groups. Rather, there are many variables which may influence a person’s desire to be
involved in a clinical trial - such as, individual motives, life span development, and health
status - just to name a few.
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Chapter 2: Literature Review
A generation is formalized as a distinct cohort of people who share birth years,
age, and unique historical, political, economic, and social life experiences at critical
developmental life stages. These shared commonalities and viewpoints help define the
uniqueness and character of each generation (Carlson, 2009). As a result of these social
categorizations, perspectives are formed and shaped which inspire mindsets toward
authority, organizations/industries, and work, as well as how to respond to and satisfy
problems (Smola & Sutton, 2002; White, 2013). This includes, for instance, Generation
Y’s viewpoint on healthcare initiatives and the clinical research enterprise.
Generation Y is a cohort of society born between 1979 and 2000, placing these
individuals, at present day, to be 14 to 34 years of age. The birth year range varies
slightly by author, but overall, this date range classifies Generation Y. A summary of
distinctive characteristics for this generation include, information seeking and
media/technology savvy, demonstrating a robust work ethic with an emphasis on
individualism, accepting change and transition adequately, displaying efforts to create a
more cultured, educated, and tolerant society, exhibiting a high self-regard, and a belief
of self-entitlement and instant gratification (Jorgenson, 2003; Ng, Schweitzer, & Lyons,
2010).
Prominent historical, political, and economic occurrences experienced by this
generation during principle developmental milestones and vulnerable formative times
consist of exceptional numbers of media-sensationalized events (see Table 1). For
example, Generation Y observed and/or experienced the effects of the financial and
housing catastrophe, fraud and deception from major corporations, terrorism,
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controversial government practices, natural disasters, schoolyard shootings, and
numerous high-profile pharmaceutical and medical device company recalls, just to name
a few. Moreover, this social media society has constantly been inundated with
advertisements fraught with individuals portrayed as victims of scams – drug and device
related deaths and recalls, occupational hazard exposures, and corporate class action law
suits.
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Table 1. Historical Events Experienced by Generation Y during Critical Developmental
Years
Event Year
U.S. involvement in Gulf War (Operation Desert Shield) 1990
51-day Waco, Texas standoff (cult members and federal agents killed) 1993
Oklahoma City domestic terrorism bombings (168 people killed) 1995
Columbine school massacre 1999
September 11: Islamic fundamentalist terrorists attacks on U.S. 2001
U.S. initiates War on Terrorism against the Taliban and Al-Qaida 2001
Enron scandal 2001
Southeast Asian tsunami (290,000 people die) 2004
Drug recalls (Cox-2 inhibitors, i.e.,Vioxx) 2004
Hurricane Katrina 2005
Subprime mortgage crisis 2007
Barack Obama takes oath as first African-American U.S. president 2009
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Chapter 3: Research Background and Methodology
The Center for Information and Study on Clinical Research Participation
(CISCRP) was established in 2003 as an “independent, Boston-based, globally focused
nonprofit organization,” focusing on educational initiatives, which include clinical
research education programs, public service campaigns, educational media, clinical trial
search technologies, and clinical trial communication programs. CISCRP also conducts
research studies intended to understand societal perceptions of clinical trials to provide
practical “insight into actionable ways that clinical research professionals can better
understand, and more effectively engage with, the public and study volunteers” (CISCRP,
2013).
Approved by an ethical review committee, and based upon the input and support
from pharmaceutical, biotechnology, contract research organizations, and investigative
sites, CISCRP conducted an online international survey between January and March
2013, titled, “The 2013 CISCRP Perceptions & Insights Study: Report on General
Perceptions.” The study objectives were aimed towards gathering a “global assessment of
public and patient perceptions, motivations, and experiences with clinical research
participation in order to monitor trends and identify opportunities to better inform and
engage the public and patients as stakeholders and partners in the clinical research
enterprise.” Additionally, CISCRP partnered with Acurian - global provider of patient
recruitment and retention services – to assist with international survey recruitment and
distribution.
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Method
Null Hypothesis
Generation Y will not be any less willing to participate in a medical research
study when compared to older age groups.
Participants
The total number of survey respondents was N=5,701. The participants were
eighteen years of age or older, of which, (75%) were North American, while the
remaining participants were South American (5%), European (15%), and Asian-Pacific
(5%). Additionally, 61% of respondents have never participated in a clinical trial, while
39% reported previous participation in a clinical trial.
Materials and Procedure
A quantitative subset analysis of the North American data (N=4276) was
conducted from the 2013 CISCRP Perceptions and Insights Study, focusing on one
question of importance, “How willing are you to participate in a clinical research study?”
Of the North American participants, N=4228, responded to this question and disclosed
age and education information. Survey response options were: “I am not sure,” “not at all
willing,” “not very willing,” “somewhat willing,” and “very willing.” The response, “I
am not sure” (N=89; 2% of participants) was omitted from the data analysis, thus revising
the sample size to N=4139.
The survey responses were explained by the following age groups: 18 – 24, plus,
25 – 34 year olds (Generation Y), compared with the responses of participants ages 35
years or older (see Table 2). The total number of survey respondents representing the 18
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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– 34 year old, Generation Y subgroup, (N=469) denoted 11 % of the North American
study population.
The dependent variable, willingness to participate in a clinical trial, was measured
on an ordinal scale consisting of four categories: 1 = not at all willing, 2 = not very
willing, 3 = somewhat willing, and 4 = very willing. The appropriate method to test for a
difference in mean scores between two groups made up of different individuals is the
independent-samples t test. The null hypothesis in this test is that the two groups have
the same mean, and a significant result rejects the null hypothesis in favor of the
conclusion that the two groups are different. The independent samples t test assumes that
the variability in scores is the same in both groups, an assumption that is known as
“homogeneity of variance.” This assumption is often violated in practice, and hence a
more conservative version of the t test is available that adjusts the degrees of freedom
used in the t test to account for differences in variability. The adjusted t test will be used
to assess the main hypothesis given that it requires fewer assumptions that the traditional
t test.
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Table 2. Number of North American Respondents by Age Group (CISCRP, 2013)
Age Range Number of Respondents Respondent Percentage (n = %)
18 – 24 121 3
25 – 34 348 8
35 – 44 638 15
45 – 54 1,032 24
55 – 64 1,253 30
65 – 74 645 15
75+ 191 5
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Chapter 4: Results
The mean response among 18 to 34-year olds was 3.46 (SD ± .686), and the mean
response among subjects 35 and older was 3.59 (SD ± .554). This shows that average
responses are lower among younger respondents compared to older ones. An
independent samples t-test adjusted for unequal group variances revealed that this
difference was statistically significant (t (524.21) = 3.771, p < .001), meaning that it is
possible to reject the null hypothesis that the two groups are equal. Statistical
significance is not always the same as clinical significance, however, so Cohen’s d was
also calculated as an effect size. According to Cohen (1988), values of Cohen’s d equal
to .2 or less indicate a small effect size, values around .5 indicate a medium effect size,
and values around .8 indicate a large effect size. The estimate of Cohen’s d for these data
was .222, indicating that the effect size was closer to the small end of the scale than the
medium point.
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Figure 2. Willingness to Participate in a Clinical Research Study – How Willing
Figure 2. Graphical representation of survey respondent data stating respondent’s willingness to
participate in a clinical research study. Adapted from The Center for Information & Study on Clinical
Research Participation (CISCRP), 2013, 2013 Perceptions and insights study: Public and patient
perceptions of clinical research. Retrieved on November 15, 2013, from http://www.ciscrp.org/
professional/reports/
1%7%
36%
56%
1% 2%
36%
61%
0%
10%
20%
30%
40%
50%
60%
70%
Not at all willing Not very willing Somewhat willing Very willing
Age Ranges
2013 CISCRP North American Age-Based Data"How willing are you to partcipate in a clinical research
study?"
18 - 34
35 +
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Chapter 5: Discussion
Based upon the quantitative subset analysis of the 2013 CISCRP Perceptions and
Insights Study: Public and Patient Perceptions of Clinical Research, the Generation Y
subgroup did harbor a more negative view of clinical trials and were less willing to
participate in a medical research study, as compared with older age groups (see Figure 2).
These results are indicative of generational differences. Furthermore, these findings can
be reinforced as a review of the literature revealed ancillary findings of the Trauth et al.
(2000) survey conducted in 1994 (see Figure 3), which sought to determine the
willingness of respondents to participate in a clinical research study. The Trauth et al.
survey results were of interest to determine if the differences seen between age groups are
truly generational, rather than maturational.
The 18 – 34 year olds in the 2013 CISCRP study represent Generation Y, whereas
the 18 – 34 year olds in the 1994 Trauth et al. study represent Generation X due to the
date in time. The results displayed in the 2013 CISCRP chart (Figure 1) represent age-
based data stating the percentage of respondents “not at all willing” to participate in a
clinical research study. Clearly, the Generation Y subgroup stands out yielding the
highest percentage (5%) of the respondent population as least willing to contribute to the
clinical research enterprise. However, in the 1994 Trauth et al. study, the then, 18 – 34
year old subgroup, classified as Generation X, represents the highest percentage of
respondents (56.8%) willing to participate in a clinical research.
To acquire a more comprehensive overview of the Generation Y subset in regards
to clinical trial participation, initial questions presented in the 2013 CISCRP Perceptions
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and Insights Study, such as understanding what is meant by the term “clinical research
study,” and rating one’s “general knowledge about clinical research” must be reviewed
foundationally to delineate between age-based maturational distinctions and progress
towards value differences related to clinical trial participation – such as viewing temporal
aspects, social media influence, information seeking characteristics, and generational
value factors. For example, the 18 – 34 year old population typically presents with fewer
health conditions and concerns as compared with older persons and generations.
Although, these younger individuals tend to encompass the value of health and
demonstrate concern, their main focus, however, is on preventative measures, such as
weight control, healthy living habits (exercise and diet), and disease prevention.
Therefore, because a clinical trial is defined as a “prospective biomedical or behavioral
research study of human subjects that is designed to answer specific questions about
biomedical or behavioral interventions,” understanding what is meant by the term clinical
research study may have fewer applicability and significance to this younger population –
they are in less demand of this targeted information (NIH, 2013, para 17).
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Figure 3. Willingness to Participate in a Clinical Research Study – 1994 Trauth
Figure 3. Graphical representation of survey respondent data stating respondents are “willing” to
participate in a clinical research study. Adapted from Trauth, J. M., Musa, D. Siminoff, L., Jewell, I.
K., Ricci, E. (2000). Public attitudes regarding willingness to participate in medical research studies.
Journal of Health and Social Policy, 12(2), 23-43. doi: 10.1300/J045v12n02_02
56.8%
49.2% 47.7%
30.6%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
18-34 35-44 45-64 65+
1994 Trauth Age-Based Data"Willing"
18-34 35-44 45-64 65+
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Temporal Factors
Rating one’s general knowledge of clinical research may also be temporally
related. Generation Y was born between the years of 1979 – 2000. However, many of the
medical breakthroughs that affected the population and had significant epidemiological
consequences that took place prior to their existence. The treatment of diabetes,
vaccinations for diphtheria, pertussis, tuberculosis, and tetanus, and the discovery of
penicillin took place in the 1920’s. Vaccinations for yellow fever and typhus, along with
blood banking, and the creation of the heart-lung machine happened in the 1930’s. The
antibiotic streptomycin, vaccinations for influenza and polio, and development of the
cardiac pacemaker occurred in the 1940’s and 1950’s. Vaccinations for measles, mumps,
rubella, chicken pox, and pneumonia took place in the 1960’s and 1970’s (Pearson
Education, 2007). Each of these medical advances produced a tangible impact for the
older subgroups, while providing monumental strides in healthcare for the future
generations.
Many of the aforementioned diseases had been eradicated and have not been seen
or experienced by Generation Y, whereas the older age groups were and may continue to
be deeply affected by these conditions. Older generations may have experienced the
death of a family member due to influenza, male infertility due to mumps, or post-polio
syndrome as the result of the acquiring the poliovirus as a child. Although medical
breakthroughs have continued to occur throughout the known lifetime of the Generation
Y subgroup, such as with the advent of vaccinations for hepatitis or the treatment of
AIDS, Generation Y may have been too young to realize the epidemiological impact.
Therefore, Generation Y’s lack of general knowledge about clinical research, as
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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compared with the older age groups may be temporally related, versus differences in
generational values.
Social Media
As temporal factors relate to the understanding of what is meant by the term
clinical research study and rating one’s knowledge about clinical research, aspects of
generationalism do impact social media practice and the perception of clinical trial safety.
According to CISCRP (2013), more than 60% of the 18 – 34 year old population have
engaged in social media forums to learn about clinical research, and while human subject
recruitment for clinical trial participation presents as a significant problem to the
biomedical industry, social media usage may open many opportunities for Generation Y
to uphold the importance of clinical research and continue to strive toward the pursuit of
scientific advancement through education and contribution.
To help solve human subject recruitment issues, social media usage offers a
valuable marketing tool for sponsors to target a wide range of demographics, especially
reaching out to the Generation Y subgroup. For example, in 2014, greater than 80% of
persons from Generation Y are internet-users, while more interestingly, Generation Y
represented the highest percentage of internet-users (>20%) actively seeking specific
information about experimental treatments or medicines (Pew Research Center, 2014).
Websites, such as ClinicalTrials.gov provide information seekers with comprehensive
resources to learn about clinical studies. Additionally, ClinicalTrials.gov offers users the
ability to set up Rich Site Summary or Really Simple Syndication (RSS) feeds to receive
trial related information and updates. However, these web-based conveniences are not
social media centered and require the user to actively pursue the content.
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Digital Revolution and Information Seeking
Generation Y has grown up during a digital revolution – they value the use of and
are sophisticated consumers of technology – Generation Y are e-learners, therefore,
websites such as ClinicalTrials.gov appears to be yet another resource in reaching this
population of society (Allerton, 2001). Furthermore, in a 2013 Research America poll,
53% of survey respondents reported hearing about clinical trials via the Internet, but cited
lack of trust and information as barriers to clinical trial participation.
Equipped with this information, sponsors knowingly have access to this
demographic, and should use social media to educate this critical and cynical audience
about the value of clinical research. To reinforce this, according to a survey of 500
Generation Y’s, 68% of Generation Y news sources are obtained via social media
sources; however, 66% of this population are not confident that the news they receive is
accurate (YPULSE, 2013).
Lack of confidence in information presented via social media sources may
directly impact the perception of clinical trial safety, as well as present a noteworthy
barrier to sponsor marketing and education. Yet, it does yield useful evidence regarding
the methods of information exchange for and information-seeking behavior of this
generation. They want the facts, and are willing to pursue other online resources to ensure
the integrity and accuracy of the information. In fact, more than 70% of the Generation Y
population use the Internet to seek information about health related issues (Pew Research
Center, 2014).
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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Generational Value Factors
Most importantly, why does Generation Y represent the highest percentage of the
CISCRP 2013 survey respondents not at all willing or not very willing to participate in a
clinical research study? Temporal factors have been explored and discussed, coupled with
the generational importance placed on technology regarding the perception of clinical
trials, but what are the generational thinking and value factors influencing the context of
and basis for choices in the milieu of Generation Y clinical trial participation?
Overarching themes in the literature are abundant with this generation’s defining
characteristics.
Generation Y has been coined by some as “Generation Me,” and has been
deemed, by some reviewers, as having a pampered upbringing, serving to signify the
individualistic nature of this cohort (Ng, Schweitzer, & Lyons, 2010). In a recent study
evaluating generational changes in “community feeling,” Generation Y was found to
have greater civic and political disengagement, more emphasis on materialistic principles,
and demonstrate less concern towards helping the public at large than were Generation X
and Baby Boomers at the same ages (Twenge, Campbell, & Freeman, 2012). This
information is further strengthened by the 1994 Trauth et al., study findings, which show
the then 18 – 34 year old subgroup (Generation X), were the most willing age group to
participate in a clinical research study. Furthermore, the 18 – 34 year olds in the Trauth et
al., study did not even have comparable access to the Internet for information exchange.
Considering that clinical research or investigations are designed to contribute to
generalizable knowledge, meaning the greater good of society, it is apparent that the
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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suggested individualistic values Generation Y upholds would hinder their willingness to
participate in a clinical trial.
Moreover, Generation Y has been referred to as harboring a sense of self-
centeredness, narcissism, and entitlement. They place greater importance on extrinsic
values, as compared to intrinsic values, such as concern for others (Twenge et al., 2012).
For example, in the corporate workplace, they have been cited for their inpatient nature,
combined with their unrealistic expectations for career advancement, despite job
performance (Ng et al., 2010). In other corporate circumstances, they need continual
positive reinforcement, nurturing, and tangible recognition – to the point of companies
hiring “praise teams.” Furthermore, this generational group has been in the spotlight for
not taking responsibility for their own actions, while expecting others to pay the
consequences of their mistakes (Aspen Education Group, 2011).
Thus, this same value system is reflective in and can be applied to and correlated
with Generation Y’s lack of willingness towards clinical trial participation. In light of
their perceived sense of narcissism and self-centered traits and features, Generation Y
may take for granted the altruistic nature of those subjects contributing to the medical
sciences – those who are bearing the burdens of clinical research - by demonstrating
apathy or simply feeling entitled to reap the benefits of the research. They may lack the
sense of shared responsibility or public health impact their contribution could make, yet
they are very driven by creating tolerance for individualism and advocating for social
change.
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Chapter 6: Conclusion
The analysis of the 2013 CISCRP and 1994 Trauth et al., study findings has led to
the rejection of the null hypothesis. Generational disparities do exist among age groups
related to the perceptions of and willingness for clinical trial participation. Although
temporal factors must be taken into account when attempting to understand why
Generation Y harbors negative views of and are the least inclined cohort to participate in
a clinical trial, generational value factors, versus simply age, certainly offer objective
support via corporate and sociological study findings. These conclusions are not proposed
to cast a negative view about Generation Y; rather, they are intended to point out some of
the inequalities that exist among generations or age groups, notably viewing the impact as
it relates to clinical trial participation and the future of our advancing global healthcare
initiatives.
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
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References
Brintnall-Karabelas, J., Sung, S., Cadman, M. E., Squires, C., Whorton, K., & Pao, M.
(2011). Improving recruitment in clinical trials: Why eligible participants decline.
J Empir Res Hum Res Ethics, 6(1), 69-74. doi:10.1525/jer.2011.6.1.69
Carlson, E. (2009). 20th-century U.S. generations. Population Reference Bureau, 64(1), 1-
20.
The Center for Information & Study on Clinical Research Participation (CISCRP).
(2013). 2013 Perceptions and insights study: Public and patient perceptions of
clinical research. Retrieved on November 15, 2013, from
http://www.ciscrp.org/professional/reports/
Epstein, R. M. & Peters, E. (2009). Beyond information: Exploring patients’ preferences.
JAMA, 302(2), 195-197.
Findlay, S. (2009). Outsourcing clinical trials: Growth continues. Pharmaceutical
Technology Europe, 21(5), 51-52.
Guadagnoli, E. & Ward, P. (1998). Patient participation in decision-making. Soc. Sci.
Med., 47(3), 329-339.
Getz, K., & Borfitz, D. (2003). Informed consent: A guide to the risks and benefits of
volunteering for clinical trials. Boston, MA: Thomson/CenterWatch.
Jorgensen, B. (2003). Baby boomers, generation X and generation Y? Foresigt, 5(4), 41-
49. doi: 10.1108/14636680310494753
Nappo, S. A., Iafrate, G. B., & Sanchez, A. M. (2013). Motives for participating in a
clinical research trial: A pilot study in Brazil. BMC, 13(19), 1-9. doi:
10.1186/147-2458-13-19
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
25
Ng, E. S. W., Schweitzer, L., & Lyons, S. T. (2010). New generation, great expectations:
A field study of the millennial generation. J Bus Psychol, 25, 281-292.
doi:10.1007/s10869-010-9159-4
Petryna, A. (2009). When experiments travel: Clinical trials and the global search for
human subjects [Google Books Reader]. Retrieved on November 15, 2013, from
http://books.google.com/books?hl=en&lr=&id=BnG1-
VigFi8C&oi=fnd&pg=PR10&dq=reasons+for+outsourcing+clinical+trials&ots=x
4m-IaupSE&sig=rXOGFkg_EBCFC1NLlzEu0rhXKVY#v=onepage&q=reasons
%20for%20outsourcing%20clinical%20trials&f=false
Siegal, G., Bonnie, R. J., & Appelbaum, P. S. (2012). Personalized disclosure by
information-on-demand: Attending to patients’ needs in the informed consent
process. Journal of Law, Medicine, and Ethics, 359-367.
Smola, K. W. & Sutton, C. D. (2002). Generational differences: Revisiting generational
work values for the new millennium. Journal of Organizational Behavior, 23,
363-382. doi: 10.1002/job.147
Stunkel, J., & Grady, C. (2011). More than money: A review of the literature examining
healthy volunteer motivations. Contemporary Clinical Trials, 32, 342-352.
Trauth, J. M., Musa, D. Siminoff, L., Jewell, I. K., Ricci, E. (2000). Public attitudes
regarding willingness to participate in medical research studies. Journal of Health
and Social Policy, 12(2), 23-43. doi: 10.1300/J045v12n02_02
Verheggen, F. W. S. M., Nieman, F. Jonkers, R. (1998). Determinants of patient
participation in clinical studies requiring informed consent: Why patients enter a
clinical trial. Patient Education and Counseling, 35, 111-125.
GENERATIONAL DIFFERENCES IMPACTING TRIAL PARTICIPATION
26
White, J. (2013). Thinking generations. The British Journal of Sociology, 64(2), 216-247.
Woolley, M. & Propst, S. M. (2005). Public attitudes and perceptions about health-related
research. JAMA, 294, 1380-1384.